Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “circuitry” in claim 1 and throughout the claims. While in some instances “circuitry” means a particular structure (e.g. Mass. Inst. of Tech., 462 F.3d at 1355-1356, cited at MPEP 2181), that appears to be when circuitry is hardware and not some other combination. ’Microsoft urges that “circuitry” should be limited to hardware whereas MIT urged below that it should include both hardware and software. We conclude that the term “aesthetic correction circuitry” is clearly limited to hardware.’ To the extent it is relevant, the normal meaning of “circuitry” is the same meaning given by the Federal Circuit in Mass. Inst. Of Tech.. Applicant does not appear to mean a purely hardware meaning (para. [0080]); rather, Applicant states “As utilized herein, circuitry is “operable” to perform a function whenever the circuitry comprises the necessary hardware and code (if any is necessary) to perform the function…”[0080]. This is a means-plus-function usage rather than a structural meaning of “circuitry”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6 and 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhong et al. (NPL, “An experimentally validated dynamic model for spring-driven autoinjectors”, published 2021).
Regarding claim 1, Zhong teaches an injector testing system, comprising: a camera configured to observe a needle of an injector (Fig. 7, Pg. 7, Col. 1, “The motion of the impact rod, plunger, and syringe are captured by a high-speed camera”); and control circuitry configured to: determine, based on images captured by the camera, a duration of fluid delivery by the injector (Pg. 11, Col. 1, “The injection time (typically 1–5 s) depends on the spring force, liquid volume, and liquid viscosity (Thueer et al., 2018). Fig. 12 shows the effects of initial spring force, initial air gap height, drug viscosity, and initial drug volume on the injection time.”, injection time is determined); and determine, based on the images captured by the camera, a needle extension length at a start of fluid delivery by the injector (Figs. 7 and 9, Pg. 2, Nomenclature, “Needle displacement at the start of drug delivery”).
Regarding claim 2, Zhong teaches all of the elements of claim 1, as stated above, as well as further comprising a positioning surface configured to contact a body of the injector and having an aperture through which the needle extends (Figs. 1 and 5(a), shows a typical autoinjector configuration, including a mechanical stop and aperture through which the needle extends).
Regarding claim 3, Zhong teaches all of the elements of claim 2, as stated above, as well as wherein the control circuitry is configured to determine the needle extension length based on a location of the positioning surface, a location of the body, or a predetermined point (Pg. 7, Col. 1, “To obtain the position of the syringe (Fig. 6 (a)) in each frame, a tracking target (the needle-end of the syringe) is first selected, which is identifiable and unique over the entire video sequence. Then for each frame, the position of the target is obtained by a cross-correlation based image registration technique… The displacements, which are relative movements with respect to the initial position in the first frame, are readily obtained after the positions of tracking objects for the entire video sequence are obtained. This tracking technique is applied to the rod, the plunger, the syringe, and the needle.”).
Regarding claim 4, Zhong teaches all of the elements of claim 2, as stated above, as well as further comprising an injector positioner configured to position the injector in contact with the positioning surface (Pg. 7, Col. 1, “To mimic the operation of an autoinjector described in Fig. 2, a special fixture was designed and 3D-printed to house the spring, rod, and pre-filled syringes… the fixture and testing assembly is bolted onto an optic post for vertical injection.”).
Regarding claim 5, Zhong teaches all of the elements of claim 2, as stated above, as well as further comprising an injector actuator configured to actuate the injector to expel the fluid of the injector via the needle (Fig. 1, driving rod/spring).
Regarding claim 6, Zhong teaches all of the elements of claim 1, as stated above, as well as wherein the control circuitry is configured to determine the duration of fluid delivery based on at least one of counting a number of frames in which fluid is observed in the images or monitoring a time during which fluid is observed in the images (Fig. 11, Pg. 11, Col. 1, “The injection time (typically 1–5 s) depends on the spring force, liquid volume, and liquid viscosity (Thueer et al., 2018). Fig. 12 shows the effects of initial spring force, initial air gap height, drug viscosity, and initial drug volume on the injection time.”).
Regarding claim 14, Zhong teaches all of the elements of claim 1, as stated above, as well as wherein the control circuitry is configured to determine the needle measurement location based on a predetermined search area within the images captured by the camera (Pg. 7, Col. 1, “To obtain the position of the syringe (Fig. 6 (a)) in each frame, a tracking target (the needle-end of the syringe) is first selected, which is identifiable and unique over the entire video sequence. Then for each frame, the position of the target is obtained by a cross-correlation based image registration technique… The displacements, which are relative movements with respect to the initial position in the first frame, are readily obtained after the positions of tracking objects for the entire video sequence are obtained. This tracking technique is applied to the rod, the plunger, the syringe, and the needle.”).
Regarding claim 15, Zhong teaches all of the elements of claim 1, as stated above, as well as wherein the control circuitry is configured to determine the duration of fluid delivery as a total observed fluid delivery time or as a total start to end time (Fig. 11. “The temporal evolution of the air gap pressure, air gap temperature, delivered drug velocity, and delivered drug volume”; Pg. 11, Col. 1, “The injection time (typically 1–5 s) depends on the spring force, liquid volume, and liquid viscosity. Fig. 12 shows the effects of initial spring force, initial air gap height, drug viscosity, and initial drug volume on the injection time.”).
Regarding claim 16, Zhong teaches all of the elements of claim 1, as stated above, as well as wherein the control circuitry is configured to monitor, based on the images captured by the camera, the needle extension length from the start time to the end time (Figs. 9-10, Pg. 7, Col. 1, “The displacements, which are relative movements with respect to the initial position in the first frame, are readily obtained after the positions of tracking objects for the entire video sequence are obtained. This tracking technique is applied to the rod, the plunger, the syringe, and the needle.”; Pg. 11, Col. 1, “The injection time (typically 1–5 s) depends on the spring force, liquid volume, and liquid viscosity. Fig. 12 shows the effects of initial spring force, initial air gap height, drug viscosity, and initial drug volume on the injection time.”).
Regarding claim 17, Zhong teaches all of the elements of claim 1, as stated above, as well as wherein the control circuitry is configured to determine the duration of fluid delivery by: determining, based on images captured by the camera, at least one of a start time or a starting image frame at which fluid begins to be expelled from the needle; and determining, based on images captured by the camera, at least one of an end time or an ending image frame at which the needle has completed expelling of the fluid (Fig. 11, Pg. 11, Col. 1, “The injection time (typically 1–5 s) depends on the spring force, liquid volume, and liquid viscosity. Fig. 12 shows the effects of initial spring force, initial air gap height, drug viscosity, and initial drug volume on the injection time.”).
Regarding claim 18, Zhong teaches all of the elements of claim 1, as stated above, as well as wherein the control circuitry is configured to determine the needle extension length by determining, based on images captured by the camera, a needle measurement location with respect to a reference location at the start of fluid delivery (Pg. 7, Col. 1, “To obtain the position of the syringe (Fig. 6 (a)) in each frame, a tracking target (the needle-end of the syringe) is first selected, which is identifiable and unique over the entire video sequence. Then for each frame, the position of the target is obtained by a cross-correlation based image registration technique… The displacements, which are relative movements with respect to the initial position in the first frame, are readily obtained after the positions of tracking objects for the entire video sequence are obtained. This tracking technique is applied to the rod, the plunger, the syringe, and the needle.”).
Regarding claim 19, Zhong teaches all of the elements of claim 1, as stated above, as well as wherein the control circuitry is configured to determine, based on the duration and the needle extension length at the start of fluid delivery, whether the injector satisfies predetermined injection criteria (Pg. 1, Col. 1, “This kind of variability influences the performance of the autoinjectors, and design engineers need to ensure the autoinjectors perform well within the expected range of parameters.”; Fig. 9, “Comparison between experimental results and model prediction for the needle displacement at the start of drug delivery.”; Fig. 11, Pg. 11, Col. 1, “The injection time (typically 1–5 s) depends on the spring force, liquid volume, and liquid viscosity. Fig. 12 shows the effects of initial spring force, initial air gap height, drug viscosity, and initial drug volume on the injection time.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 11-13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong.
Regarding claim 11, Zhong teaches all of the elements of claim 1, as stated above, as well as wherein the control circuitry is configured to determine whether the injector satisfies the predetermined injection criteria based on duration of fluid delivery (Pg. 1, Col. 2, “This kind of variability influences the performance of the autoinjectors, and design engineers need to ensure the autoinjectors perform well within the expected range of parameters.”; Pg. 11, Col. 1, “The injection time (typically 1–5 s) depends on the spring force, liquid volume, and liquid viscosity (Thueer et al., 2018). Fig. 12 shows the effects of initial spring force, initial air gap height, drug viscosity, and initial drug volume on the injection time.”, injection time is determined)).
Zhong does not explicitly disclose that the fluid delivery satisfies a threshold. However, they disclose that autoinjectors need to be verified in order to ensure they perform within an expected range of parameters, with duration of fluid delivery being a disclosed parameter (Pg. 1, Col. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zhong to include that the fluid delivery satisfies a threshold. Zhong discloses a method for analyzing injection performance with many parameters being verified to ensure they fall within an expected range. They further disclose determining the duration of fluid delivery. One of ordinary skill in the art would have understood that a threshold is a well-known technique to ensure that performance satisfies expected conditions and predictably implemented a threshold in view of Zhong’s method to verify that injection performance operates within expected ranges.
Regarding claim 12, Zhong teaches all of the elements of claim 1, as stated above, as well as wherein the control circuitry is configured to determine whether the injector satisfies the predetermined injection criteria based on whether the needle extension length at the start time is at least a threshold length (Fig. 9, “Comparison between experimental results and model prediction for the needle displacement at the start of drug delivery.”, See analysis of claim 11 above).
Regarding claim 13, Zhong teaches all of the elements of claim 1, as stated above, as well as further comprising a second camera configured to record video of the needle of the injector (Pg. 7, Col. 1, “The motion of the impact rod, plunger, and syringe are captured by a high-speed camera.”, A camera is disclosed as being used to image the injector, one of ordinary skill in the art would have recognized that implementing a second camera would predictably improve detection accuracy by including more angles of the injector as well as redundant imagery for analysis.).
Regarding claim 20, Zhong teaches all of the elements of claim 19, as we all as wherein the control circuitry is configured to determine whether the injector satisfies the predetermined injection criteria further based on whether the needle extension length between the start of the fluid delivery and an end of the fluid delivery satisfies a threshold length (See the analyses of claims 16 and 11 above. In view of Zhong’s needle extension length displacement determination, determination of fluid delivery duration, and their disclosure of ensuring that injection performance falls within the expected range of parameters, it would have been obvious to monitor needle extension length between the start and end of fluid delivery to determine whether it satisfies a threshold length to fully ascertain injection performance.).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Zhong in view of Yang et al. (US Patent Pub. No. 2020/0009861 A1, published 2020).
Regarding claim 7, Zhong teaches all of the elements of claim 1, as stated above, as well as wherein the control circuitry is configured to analyze the images captured by the camera to detect at least one of a start of the duration of fluid delivery or an end of the duration of fluid delivery (Pg. 11, Col. 1, “The injection time (typically 1–5 s) depends on the spring force, liquid volume, and liquid viscosity (Thueer et al., 2018). Fig. 12 shows the effects of initial spring force, initial air gap height, drug viscosity, and initial drug volume on the injection time.”, injection time is determined).
Zhong does not explicitly disclose detecting this duration based on detecting a presence of a stream of fluid expelled from the needle.
Yang teaches wherein the control circuitry is configured to analyze the images captured by the camera to detect a presence of a stream of fluid expelled from the needle (Para. 9, “a camera obtaining an image of the liquid discharged from the nozzle by being arranged toward the nozzle.”; Para. 63, “For example, the apparatus for detecting the liquid discharge characteristics may be used for detecting the discharge characteristics of the liquid discharged from the nozzle in a state of a liquid column, atomization, or a droplet.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zhong to incorporate the teachings of Yang to include detecting at least one of a start of the duration of fluid delivery or an end of the duration of fluid delivery based on detecting a presence of a stream of fluid expelled from the needle. Zhong discloses detecting the duration of fluid delivery during an injection, however they do not explicitly disclose how this detection is performed. Yang discloses that generally, liquid is discharged from a nozzle with a fixed quantity, providing a need for the detection of liquid discharge characteristics of a liquid discharged from a nozzle (Para. 3). They provide a method for this that detects liquid discharge from a wide variety of nozzles by analyzing images of the nozzle. One of ordinary skill in the art would have understood that injection time is an important parameter to consider when verifying the performance of an injection, as it can be affected by numerous variables (Zhong; Pg. 11, Col. 1), providing a clear motivation to supplement Zhong’s autoinjector verification method with Yang’s method of liquid discharge detection for more robust injection time detection.
Claim(s) 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhong as modified in view of Yang, further in view of Smith (US Patent No. 4,844,297 A, published 1989).
Regarding claim 8, Zhong as modified in view of Yang teaches all of the elements of claim 7, as stated above, as well as detecting an end of the stream of fluid. They do not explicitly disclose further comprising a blowoff nozzle configured to direct gas toward the needle.
Smith teaches further comprising a blowoff nozzle configured to direct gas toward the needle, wherein the control circuitry is configured to control the blowoff nozzle to direct the gas toward the needle based on detecting an end of the stream of fluid (Para. 20, “ …gas under pressure, preferably compressed air, is blown across the outside of the nozzle member discharge aperture to remove any remaining fluid material hanging therefrom.”, they blow gas to remove remaining fluid, indicating it is based on a detection of an end of the stream of fluid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Zhong and Yang to incorporate the teachings of Smith to include a blowoff nozzle configured to direct gas toward the needle, wherein the control circuitry is configured to control the blowoff nozzle to direct the gas toward the needle based on detecting an end of the stream of fluid. The modified system of Zhong and Yang discloses the ability to detect the end of a stream of fluid, however they do not explicitly disclose the inclusion of a blowoff nozzle to direct gas towards the needle at the end of the stream of fluid. Smith teaches a method for determining an amount of dispensed fluid, as well as the inclusion of a blowoff nozzle to direct gas towards the nozzle member to remove remaining fluid material. Although Smith is not in the same field of endeavor, it is reasonably pertinent to the particular problem of accurate measurement of fluid discharge. One of ordinary skill in the art would have understood that a nozzle dispensing fluid (such as a needle) has the possibility to leave residual fluid behind which may cause erroneous measurements, providing incentive to look to the broader fluid-dispensing art, such as Smith, for a solution. Including the blowoff cleaning nozzle of Smith in the modified system of Zhong and Yang would have been a predictable variation using known techniques in order to ensure performance verification of fluid delivery is completed accurately.
Regarding claim 9, Zhang as modified in view of Yang and Smith teach all of the elements of claim 8, as well as further comprising a scale configured to measure a mass of the expelled fluid (Smith; Col. 3, Lines 53-61, “…apparatus for dispensing desired weights of a plurality of fluid materials… including a plurality of dispensing apparatus as hereinbefore described, one for each particular fluid material to be dispensed, at least one weighing scale and at least one receptacle on the scale for receiving the or each liquid material”, Using a scale is a well-known technique to accurately measure an amount of expelled fluid).
Regarding claim 10, Zhang as modified in view of Yang and Smith teach all of the elements of claim 9, as stated above, as well as wherein the control circuitry is configured to control the scale to determine the mass of the expelled fluid following the controlling of the blowoff nozzle to direct the gas toward the needle (See analysis of claim 8. One of ordinary skill in the art would have recognized that the blowoff nozzle is activated at the end of fluid delivery to clean the nozzle (as disclosed by Smith). This would help remove the possibility of a trailing droplet influencing measurements, leaving it obvious to control the scale to determine the mass after performing the cleaning.).
Conclusion
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/DAVID ALEXANDER WAMBST/Examiner, Art Unit 2663
/GREGORY A MORSE/Supervisory Patent Examiner, Art Unit 2698
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